Monday, December 3, 2012

Supreme Court Grants Certiorari in Myriad Gene Patent Case

On November 30, the Supreme Court granted certiorari in AMP v. Myriad (commonly referred to as
the "Myriad" case), as reported on other blogs such as Patently-O,
Patent Docs and Pharmapatentblog. There were three questions presented in the plaintiff's
petition for certiorari, but the Supreme Court granted the petition with
respect to only one -"Are human genes patentable?"

The other questions presented in the petition, but not taken
up by the Supreme Court, addressed the Federal Circuit's decision upholding the
patent eligibility of Claim 20 (a method of using genetically modified cells to
screen for drug candidates) and the issue of standing. The Courts decision to
let the Federal Circuit's decision regarding claim 20 stand comes as welcome news,
because were the Supreme Court to declare the claim patent ineligible it could
have had potentially serious negative ramifications for innovation in health
sciences.

It will be interesting to see what the Supreme Court does
with the case. The manner in which the plaintiff's framed the question for
appeal is somewhat misleading. It has long been well established that human genes
per se (as they exist naturally in the human body) are not patent
eligible.The Myriad "gene
patent" claims at issue in the case do not encompass human genes as they
exist in the body, but rather are limited to "isolated" DNA molecules
corresponding structure to naturally occurring gene sequences. So the question
is, to what extent might the Supreme Court decide the case in a manner which
imposes new constraints on patent eligibility relative to the conventional
understanding of the patent office and most patent practitioners, i.e., that
naturally occurring biomolecules, including DNA, are patent eligible in their
isolated form.

The Supreme Court could find some of Myriad's isolated DNA
patent claims patent ineligible without invalidating most issued isolated DNA
claims. In particular, the US Solicitor General’s amicus brief at the Federal
Circuit argued that claims encompassing isolated genomic DNA sequences are
patent ineligible, while claims to isolated cDNA sequences should be considered
patent eligible.I have argued that the
Solicitor General's distinction between isolated genomic DNA and cDNA is not
supported by the science, but were the Court to adopt it, it would likely
result in patent eligibility for most gene patent claims. I have conducted
empirical research looking at hundreds of gene patents, and the vast majority
of isolated DNA claims appear to be directed towards cDNA, not isolated genomic
DNA.

Of course, the Supreme Court could go further, and find that
not only isolated genomic DNA, but also isolated cDNA claims are patent
ineligible. Or it could go further still, and find that claims to
isolated/purified biomolecules in general are patent ineligible. As I have discussed
previously, there are many important patents directed towards isolated proteins
and other naturally occurring biological molecules. The Biotechnology Industry
Organization (BIO) provided numerous examples in their amicus brief filed with
the Federal Circuit. Under the rationale used by the District Court in finding
Myriad’s isolated DNA claims patent ineligible, it would seem that mere purification/isolation
of a naturally occurring molecule would be insufficient to render it patent
eligible.

In Judge Lourie’s majority opinion for the Federal Circuit,
he made a point of distinguishing between isolated DNA molecules and purified
naturally occurring molecules. He found it significant that, according to his
understanding, isolation of DNA inherently involves cleaving covalent bonds, rendering
Myriad’s claimed isolated DNA structurally distinct from its naturally
occurring counterpart. This allowed him to conclude that Myriad’s isolated DNA
claims are patent eligible, while leaving undecided the question of whether purification
of a naturally occurring molecule (without cleavage of covalent bond or other
structural change) would be sufficient to render it patent eligible. I have
suspected that perhaps he made this distinction in order to narrow the scope of
his ruling, and hopefully avoid the Supreme Court taking the case. After the Prometheus decision, it would not
surprise me if at least some Justices on the Supreme Court would reject the
notion that purification of a naturally occurring molecule renders it patent
eligible.

The irony is that, in my view, the whole furor over isolated
DNA claims is something of a tempest in a teapot. In 2012, I just don't believe
that claims to isolated human DNA are that relevant. In 2007, I published the
results of a study I conducted which looked at all instances of human gene
patent litigation in the United States (using a relatively broad definition of
"human gene patent"). In that study, I only found two cases in which
an isolated DNA claims was successfully asserted against an infringer. One of
these cases was Amgen v. Chugai
(claim 2 of US Patent No. 4,703,008), decided in 1993, and the other was Promega v. Lifecodes, a relatively
obscure case from the 1990s with claims directed towards specific, non-protein
encoding genomic sequences useful as "DNA fingerprints" for forensics
and paternity testing (US Patent No. 4,963,663).

Significantly, in Amgen
v. Chugai claims 4 and 6 were also found valid and infringed, and these
claims are directed towards recombinant cells transformed or transfected with
the claimed erythropoietin gene. In subsequent cases, Amgen again prevailed
against competitors based on infringement of claims directed towards
recombinant cells and vectors, the protein product of the gene, and methods of
using and producing the product (see Amgen
v. Hoechst Marion Roussel and Amgen
v. Hoffman-La Roche).In other
words, the isolated DNA claim was probably not necessary in order for Amgen to
effectively protect its invention.

Since I conducted my study, I have seen a few subsequently
filed cases involving genetic testing and gene patents, but invariably the
asserted patent claims are method claims, not isolated DNA claims. I think
these method claims are much more relevant for innovation in diagnostics and
personalized medicine. Of course, the patent eligibility of these sorts of
methods has been called into question by the Supreme Court's recent decision in
Prometheus.

As far as product claims go, it should be possible for
innovators to draft claims that have some value and which would be patent
eligible regardless of how the Supreme Court decides Myriad. For example, Amgen did not just obtain a patent claim to
the isolated erythropoietin gene, but also to recombinant vectors comprising
the gene, recombinant cells comprising the gene and/or vector, claims to the
therapeutic protein product, and a variety of method claims, all of which will
very likely remain patent eligible.

As Myriad has long pointed out, the publication of the
sequence of the human genome and other developments since the last century will
make it difficult going forward to obtain new patents claiming isolated human
genes. Method claims will likely be much more important for protecting future
genetic discoveries. Most of the human gene patents in existence probably arise
from work conducted prior to the turn-of-the-century, and they are already
beginning to expire. Despite the ongoing concern, there is little to suggest
that isolated DNA claims of the type at issue in this case have been a problem,
or will develop into a problem, warranting Supreme Court intervention. But it's
not too surprising that the Court took the case, given the number of amicus
briefs filed in support of the petition, by groups such as the National Woman's
Health Network and American Medical Association, as discussed on a post to Patent
Docs.

About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.